ABSTRACT
The routine testing of excipients prior to their use in the manufacture of solid oral dosage forms is usually restricted to simple tests that confirm their identity and chemical purity. Whilst most excipient suppliers will guarantee that their products will also pass the tests described in the major pharmacopeias, the results of these testing procedures are likely to tell the end user very little about the functionality of the excipients during normal pharmaceutical manufacturing operations. This is especially true when small differences in primary material properties, such as molecular weight or particle size, can bring about significant changes in ultimate manufacturing performance, such as compressibility.
